A lengthy new FTC report on “Follow-on Biologic Drug Competition" issued June 10, 2009 concludes that:

  • Competition between a biologic drug and a follow-on biological (FOB) is much more likely to resemble brand-to-brand competition than the dynamics of brand-generic competition under Hatch-Waxman.
  • Existing incentives that support brand-to-brand competition among biologic drugs – patent protection and market-based pricing – are likely to be sufficient to support FOB competition and biologic innovation.
  • A 12-14-year exclusivity period is unnecessary to promote innovation by pioneer biologic drug manufacturers.
  • Special procedures to resolve patent issues between pioneer and FOB drug manufacturers prior to FDA approval are unnecessary and they could undermine patent incentives and harm consumers.
  • FOB drug manufacturers are unlikely to need additional incentives to develop interchangeable FOB products.

The FTC paper will be the subject of a June 11 Energy and Commerce Health Subcommittee hearing.